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    Summary
    EudraCT Number:2018-001098-26
    Sponsor's Protocol Code Number:MK-7264-034
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-08-24
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2018-001098-26
    A.3Full title of the trial
    A Phase 2a, Proof of Concept, Randomized, Double-blind, Placebo-controlled Clinical Trial, to Evaluate the Efficacy and Safety of MK-7264 in Women with Moderate to Severe Endometriosis-related Pain
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MK-7264 Phase 2a in Women with Endometriosis-related Pain
    A.3.2Name or abbreviated title of the trial where available
    MK-7264 Phase 2a in Women with Endometriosis-related Pain
    A.4.1Sponsor's protocol code numberMK-7264-034
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code MK-7264
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNgefapixant
    D.3.9.1CAS number 1015787-98-0
    D.3.9.2Current sponsor codeMK-7264
    D.3.9.3Other descriptive nameAF-219
    D.3.9.4EV Substance CodeSUB184344
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to severe Endometriosis-related pain (ERP)
    E.1.1.1Medical condition in easily understood language
    Moderate to severe Endometriosis-related pain (ERP)
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10014788
    E.1.2Term Endometriosis related pain
    E.1.2System Organ Class 100000004872
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1) To evaluate the efficacy of MK-7264 versus placebo in reducing average daily pelvic pain (cyclic and non-cyclic, combined) during Treatment Cycle 2 (TRC2) as measured by a numeric rating scale (NRS) in the daily eDiary
    2)To evaluate the safety and tolerability of MK- 7264
    E.2.2Secondary objectives of the trial
    1) To evaluate the efficacy of MK-7264 versus placebo in reducing average daily cyclic pelvic pain during TRC2 as measured by an NRS in the daily eDiary
    2) To evaluate the efficacy of MK-7264 versus placebo in reducing average daily non-cyclic pelvic pain during TRC2 as measured by an NRS in the daily eDiary
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Merck will conduct Future Biomedical Research on DNA (Blood) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time
    E.3Principal inclusion criteria
    1. Participant has been surgically (laparoscopy or laparotomy) diagnosed with endometriosis within 10 years of study entry as documented by medical records
    2. Participant has cyclic (secondary dysmenorrhea) AND non-cyclic, moderate to severe endometriosis-related pelvic pain, as confirmed by an overall score of ≥5 at Visit 1 based on the participant’s last 2 menstrual cycles using an NRS (0 10 anchored with 0 [no pain] and 10 [extremely severe pain])
    3. Participant has had spontaneous, (ie, without hormonal therapy) regular, menstrual cycles with a cycle length between 24 to 38 days (inclusive) for the past 2 months before Visit 1.
    4. Participant is a female
    5. Participant is from 18 years to 49 years of age inclusive, at the time of signing the informed consent
    6. Participant’s body mass index (BMI) is between 18 kg/m2 to 40 kg/m2 inclusive, at Visit 1
    7. Participant is not pregnant, not breastfeeding, and the following condition applies: The participant agrees to follow the contraceptive guidance from the time of signing informed consent through the last day of the post-treatment cycle of the study (Visit 7) or for at least 14 days after the last dose of double blind study intervention if the participant discontinues study intervention
    8. The participant (or legally acceptable representative, if applicable) provides written informed consent for the study. Participant must be willing and able to comply with all aspects of the protocol, including the use of the eDiary, to the satisfaction of the investigator/qualified designee before randomization. The participant may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research
    9. Participant must agree to switch from her usual analgesic medication to only that which is permitted in the study (ie, naproxen sodium rescue medication provided by the Sponsor)
    At Visit 3:
    10. Participant’s menstrual cycle before Visit 3 (SC) was 24 to 38 days (inclusive) as documented in the eDiary
    11. Participant reports at least moderate pelvic pain during the SC as defined by average daily pelvic pain (cyclic and non-cyclic) score >5
    12. Participant has demonstrated compliance with >75% of daily eDiary entries (ie, pelvic pain score, vaginal bleeding, rescue medication intake, intake of pain relief medication other than naproxen sodium provided by Sponsor, and impact of pelvic pain) during the SC
    13. Participant has taken only the study provided rescue medication, at a dose not exceeding the maximum dose determined by the investigator according to the local label, for control of ERP during the SC as evidenced in the eDiary
    At Visit 4:
    14. Participant’s menstrual cycle before Visit 4 (BC) was 24 to 38 days (inclusive) as documented in the eDiary
    15. Participant reports at least moderate pelvic pain during the BC as defined by average daily pelvic pain (cyclic and non-cyclic) score >5
    16. Participant has demonstrated compliance with >75% of daily eDiary entries (ie, pelvic pain score, vaginal bleeding, rescue medication intake, intake of pain relief medication other than naproxen sodium provided by Sponsor, and impact of pelvic pain) during the BC
    17. Participant is ≥80% compliant with the placebo run-in medication (as determined by siteperformed tablet count)
    18. Participant has taken only the study provided rescue medication, at a dose not exceeding the maximum dose determined by the investigator according to the local label, for control of endometriosis-related pelvic pain during the BC as evidenced in the eDiary
    E.4Principal exclusion criteria
    1. Participant had no pelvic pain for more than 50% of the days in her last menstrual cycle according to the participant’s recollection
    2. Participant has a surgical history of hysterectomy and/or bilateral oophorectomy
    3. Participant had undiagnosed (unexplained), abnormal, vaginal bleeding within the past 6 months before screening
    4. Participant has chronic pelvic pain not caused by endometriosis that requires chronic analgesic or other chronic therapy (including, but not limited to, pain caused by IC, BPS, adenomyosis [as confirmed by imaging], symptomatic uterine fibroids, irritable bowel syndrome, vulvodynia, or hysteroscopic sterilization)
    5. Participant has chronic, non-pelvic pain not caused by endometriosis that requires chronic analgesic or other chronic therapy (including, but not limited to, fibromyalgia, chronic back pain or chronic headaches)
    6. Participant has a clinically significant gynecologic condition identified in the screening evaluation including, but not limited to, endometriomas of any size, persistent (present longer than 4 months) complex ovarian cysts larger than 3 cm, simple ovarian cysts larger than 5 cm, or an active sexually transmitted disease. Participants may be rescreened after completing treatment for infection or for simple ovarian cysts
    7. Participant plans to schedule elective surgery during the study execution or had surgery in the past 6 months before screening that continues to require pain management
    8. Participant has a history of anaphylaxis or cutaneous adverse drug reaction (with or without systemic symptoms) to sulfonamide antibiotics or other sulfonamide-containing drugs
    9. Participant has a known allergy/sensitivity or contraindication to MK-7264 or its excipients
    10. Participant has an allergy/sensitivity/intolerance to naproxen sodium (rescue medication) or any contraindication to its use, or has experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
    11. Participant has an estimated glomerular filtration rate <50 mL/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology Collaboration [CKD EPI] formula) at Visit 1
    12. Participant has systolic blood pressure >160 mm Hg or diastolic blood pressure >90 mm Hg at Visit 1
    13. Participant is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence, per the investigator’s discretion. Participants are asked to follow a specified restrictions on alcohol use during the study
    14. Participant has a history of ERP that was non-responsive to treatment with CHCs, GnRH antagonists, GnRH agonists, progestins, or aromatase inhibitors
    15. Participant has a history of malignancy ≤5 years before signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
    16. Participant has donated or lost ≥1 unit of blood (approximately 300 mL) within 8 weeks before the first dose of MK-7264
    17. Participant has a positive urine pregnancy test at any time before randomization. If the urine test cannot be confirmed as negative, a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive
    18. Participant has required more than 2 weeks of continuous use of narcotics for treatment of ERP within 6 months of Visit 1
    19. Participant has received/must continue to receive any treatment Prohibited Medications and Other Substances as per protocol more recently than the “Last Allowable Use” .
    20. Participant has received MK-7264 in a previous clinical study
    21. Participant is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 30 days of participating in the current study
    22. Participant has clinically significantly abnormal laboratory tests at Screening, including:
    a. Alkaline phosphatase (AP), alanine aminotransferase (ALT, SGPT), aspartate aminotransferase (AST, SGOT) >200% of the upper limit of normal, or total bilirubin >150% of the upper limit of normal.
    b. Hemoglobin <10 gm/dL, white blood cell count <2500 mm3, neutrophil count <1500 mm3, platelet count <100 × 103/mm3
    23. Participant has other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator or Sponsor, would make the participant inappropriate for entry into this study
    24. Participant is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study
    E.5 End points
    E.5.1Primary end point(s)
    1) Average daily pelvic pain scores (cyclic and non-cyclic) during Treatment Cycle 2 (TRC2)
    2) The proportion of participants with adverse events (AEs)
    3) The proportion of participants with an AE which leads to discontinuation
    E.5.1.1Timepoint(s) of evaluation of this end point
    Treatment Cycle 2
    E.5.2Secondary end point(s)
    1) Average daily cyclic pelvic pain scores during TRC2
    2) Average daily non-cyclic pelvic pain scores during TRC2
    E.5.2.1Timepoint(s) of evaluation of this end point
    Treatment Cycle 2
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Naproxen sodium as Rescue Medication
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Chile
    New Zealand
    Poland
    Russian Federation
    Spain
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months14
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 166
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 166
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-10-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-06-30
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